BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2003122 · Received February 4, 2011

    Report

    Report Number
    8020030-2011-00006
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: INSTRUMENT LOGS WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION PROCESS. RESULTS: THE INSTRUMENT LOGS SHOWED THAT THE CONFIGURATION OF THE REAGENT STATIONS AND THE REAGENT THRESHOLDS DIFFERED FOR MFR RECOMMENDATIONS. THE DIFFERENCES IDENTIFIED WERE NOT CONSIDERED BY (B)(4) MICROSYSTEMS TO HAVE EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. THE PROTOCOL USED FOR THE RUN EXHIBITING SUB-OPTIMAL TISSUE PROCESSING DIFFERED MARKEDLY FROM THE EQUIVALENT MFR RECOMMENDED PROTOCOL, AND HAD BEEN EDITED BY A SUPERVISOR LEVEL USER IMMEDIATELY PRIOR TO COMMENCEMENT OF THE RUN. THE EDITED PROTOCOL WAS NOT VALIDATED ACCORDING TO THE STANDARD OPERATING PROCEDURE FOR THE LABORATORY AND/OR THE LOCAL REGULATORY GUIDELINES IN ORDER TO ENSURE THAT THE PROTOCOL MET THE PERFORMANCE REQUIREMENTS OF THE LABORATORY, AS RECOMMENDED BY (B)(4) MICROSYSTEMS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(4) MICROSYSTEMS REC'D A COMPLAINT FROM (B)(6) HOSPITAL REGARDING SUB-OPTIMAL PROCESSING RESULTING IN OVER-PROCESSED TISSUE FROM A PROTOCOL WHICH COMMENCED ON (B)(6) 2011 AND COMPLETED ON (B)(6) 2011 USING PELORIS TISSUE PROCESSOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1